BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVINCI 5

    MDR report key: 21095773 · Received January 7, 2025

    Report

    Report Number
    2955842-2025-00162
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    December 12, 2024
    Report Date
    December 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119716
    PMA / PMN Number
    K232610
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISI FSE WENT ON SITE AND REPLACED THE CFG PATIENT SIDE CART COMPUTE ENGINE (PCE) TO RESOLVE THE ISSUE WITH ERROR 319. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI RECEIVED A DA VINCI PRODUCT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 0

    ON 15-JAN-2025, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: PATIENT'S DEMOGRAPHIC INFORMATION WAS PROVIDED. (REFER TO FIELDS A2, A3A, A3B, AND A4. THE PATIENT SIDE CART COMPUTE ENGINE (PCE) WAS ANALYZED AND FOUND TO HAVE AN ERROR WHICH WAS CONFIRMED IN A REVIEW OF THE ERROR LOGS. UPON VISUAL INSPECTION, NO ISSUES WERE FOUND THAT WOULD BE RELATED TO THE REPORTED EVENT. THE UNIT WAS INSTALLED ON AN IN-HOUSE SYSTEM AND THE SYSTEM TRIGGERED THE ERROR. THE SYSTEM WAS POWER CYCLED MULTIPLE TIMES BUT THE ISSUE PERSISTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL BILATERAL HERNIA SURGICAL PROCEDURE, A 319 ERROR WAS DISPLAYED. THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) INFORMED THEY HAD ANOTHER ERROR BEFORE THIS ONE AND REBOOTED THE SYSTEM AND BEGAN GETTING THE 319 NON-RECOVERABLE ERROR. THE CSR ALSO INFORMED THEY HAVE AN INSTRUMENT GRASPING TISSUE. THE ISI TECHNICAL SERVICE ENGINEER (TSE) ADVISED THE CUSTOMER TO USE THE WRENCH TO RELEASE THE TISSUE AND REMOVE ALL INSTRUMENTS FROM THE PATIENT. THE TSE THEN HAD THE CSR POWER DOWN THE SYSTEM AND EMERGENCY POWER OFF (EPO) THE ROBOT. THE CSR POWERED THE SYSTEM BACK ON WITH A MESSAGE THAT THE BOOM WAS DISABLED AND THE 319 ERROR AGAIN. THE TSE INFORMED THAT THERE WAS NOTHING ELSE THEY COULD DO AT THIS POINT AND A FIELD SERVICE ENGINEER (FSE) WILL NEED TO CHECK THE SYSTEM. THE CSR WAS GOING TO ASK THE SURGEON HOW THEY WOULD PROCEED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER SAID THE ISSUE OCCURRED DURING THE INGUINAL BILATERAL HERNIA PROCEDURE. THE CUSTOMER WAS WORKING FOR ABOUT 40 MIN BEFORE THE SYSTEM ERROR. THE ISSUE WAS NOT RESOLVED AFTER TROUBLESHOOTING DURING THE PROCEDURE. THE CUSTOMER HAD TO ABORT TO A LAPAROSCOPIC PROCEDURE UNTIL THE FIELD ENGINEER WAS ABLE TO FIX IT; THE FULL SYSTEM WAS DOWN. ONE ADDITIONAL PORT WAS PLACED WHEN CONVERTING TO A LAPAROSCOPIC PROCEDURE. THERE WAS A PROCEDURE DELAY TRYING TO TROUBLESHOOT OF APPROXIMATELY 25-30 MIN.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834654 DAVINCI 5 PATIENT SIDE CART NAY INTUITIVE SURGICAL, INC 380747-41 N/A 00886874119716

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention DA VINCI INSTRUMENTS AND ACCESSORIES